Summary of the invention
Purpose of the present invention aims to provide a kind of preparation method that contains the Chinese traditional compound medicine of Herba Epimedii.
The objective of the invention is to realize by following method:
A, take by weighing following each crude drug by weight: 72 parts of 10 parts of Cortex Acanthopanciss, 20 parts of Herba Epimedii, 5 parts of bee pollen, 4 parts of Lac regis apis and Mel, standby;
B, Cortex Acanthopancis, Herba Epimedii are decocted with water, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected;
C, B is gone on foot the gained medicinal residues decoct with water, decocting liquid and B step gained medicinal liquid merge, and filter, and filtrate decompression is condensed into clear paste, adds alcohol, stirs, and leaves standstill, and filters, and filtrate is reclaimed alcohol, and concentrating under reduced pressure becomes clear paste again, and is standby;
D, bee pollen add saccharifying enzyme to be handled, and adds alcohol and grinds, and filters filtrate for later use;
E, Lac regis apis add alcohol and grind, and filter, and merge with D step gained filtrate, reclaim alcohol, and be standby;
F, get Mel, heating, insulation is defoamed and impurity, filters the filtrate cooling;
G, B is gone on foot gained volatile oil, C step gained clear paste and E step gained concentrated solution mixes, stir evenly;
H, F is gone on foot gained medicinal liquid and G step gained medicinal liquid mixing, add corresponding adjuvant again and be prepared into any modern preparation that allows on the pharmaceutics with the pharmacy acceptable.
Chinese traditional compound medicine preferred manufacturing procedure of the present invention, it may further comprise the steps:
A, take by weighing following each crude drug by weight: 72 parts of 10 parts of Cortex Acanthopanciss, 20 parts of Herba Epimedii, 5 parts of bee pollen, 4 parts of Lac regis apis and Mel, standby;
B, Cortex Acanthopancis, Herba Epimedii are added 2~8 times in water amount decocted 0.5~2 hour, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected;
C, B is gone on foot the gained medicinal residues add 1~5 times in water amount and decoct, decocting liquid merges with A step gained medicinal liquid again, filters, and filtrate decompression is condensed into clear paste, adds ethanol and reaches 50~60% to containing the alcohol amount, stirs, and leaves standstill, filter, and filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste again, and is standby;
D, bee pollen add saccharifying enzyme to be handled, and adds ethanol and grinds, and filters filtrate for later use;
E, Lac regis apis add ethanol and grind, and filter, and merge with D step gained filtrate, reclaim ethanol, and be standby;
F, get Mel, be heated to 80~100 ℃, insulation is defoamed and impurity, filters, and filtrate is cooled to 30~40 ℃;
G, B is gone on foot gained volatile oil, C step gained clear paste and E, step gained concentrated solution mix, stir evenly;
H, F is gone on foot gained medicinal liquid and G step gained medicinal liquid mixing, add corresponding adjuvant again and be prepared into any modern preparation that allows on the pharmaceutics with the pharmacy acceptable.
The present composition can make by the following best approach:
A, take by weighing following each crude drug by weight: 10 parts of Cortex Acanthopanciss, 20 parts of Herba Epimedii, 5 parts of bee pollen, 4 parts of Lac regis apis, standby;
B, Cortex Acanthopancis, Herba Epimedii are added 5 times in water amount decocted 1 hour, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected;
C, B is gone on foot the gained medicinal residues add 3 times in water amount and decocted 1 hour, decocting liquid merges with B step gained medicinal liquid again, filters, and filtrate decompression is condensed into clear paste, adds ethanol and reaches 50~60% to containing the alcohol amount, stirs, and leaves standstill, filter, and filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste again, and is standby;
D, bee pollen add saccharifying enzyme to be handled, and adds ethanol and grinds, and filters filtrate for later use;
E, Lac regis apis add ethanol and grind, and filter, and merge with D step gained filtrate, reclaim ethanol to there not being the alcohol flavor, and be standby;
F, get Mel, be heated to 85~95 ℃, insulation is defoamed and impurity, filters, and filtrate is cooled to 30~40 ℃;
G, B is gone on foot gained volatile oil, C step gained clear paste and E step gained concentrated solution mixes, stir evenly;
H, F is gone on foot gained medicinal liquid and G step gained medicinal liquid mixing, add corresponding adjuvant again and be prepared into any modern preparation that allows on the pharmaceutics with the pharmacy acceptable.
The preparation method of oral liquid of the present invention, it can prepare as follows:
A, take by weighing following each crude drug by weight: 72 parts of 10 parts of Cortex Acanthopanciss, 20 parts of Herba Epimedii, 5 parts of bee pollen, 4 parts of Lac regis apis and Mel, standby;
B, Cortex Acanthopancis, Herba Epimedii are added 5 times in water amount decocted 1 hour, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected;
C, B is gone on foot the gained medicinal residues add 3 times in water amount and decocted 1 hour, decocting liquid merges with B step gained medicinal liquid again, filter, filtrate decompression is condensed into clear paste, adds ethanol and reaches 50~55% to containing the alcohol amount, stir, leave standstill, filter filtrate recycling ethanol, concentrating under reduced pressure becomes relative density to be the clear paste of 1.10 (60~70 ℃ of surveys) again, and is standby;
D, bee pollen add saccharifying enzyme to be handled, and adds ethanol and grinds, and filters filtrate for later use;
E, Lac regis apis add ethanol and grind, and filter, and merge with D step gained filtrate, reclaim ethanol to there not being the alcohol flavor, and be standby;
F, get Mel, heat 80~95 ℃, insulation is defoamed and impurity, filters, and filtrate is cooled to 30~40 ℃;
G, the clear paste of volatile oil, C step gained that B is gone on foot gained and the concentrated solution of E step gained mix, and stir evenly;
H, F is gone on foot gained medicinal liquid and G step gained medicinal liquid mixing, add the potassium sorbate of admixing medical solutions cumulative volume 0.05% again, and use the citric acid adjust pH, stir evenly, promptly get the oral liquid of medicine of the present invention.
One of contained crude drug---Lac regis apis in the compound preparation of the present invention, rich in proteins, total lipid and carbohydrate etc., but also contain 18 kinds of free amino acids, comprised whole essential amino acids, other contains hormone 17-ketone sterin, 17-hydroxyl sterin, Norepinephrine, accessory suprarenal glands element, hydrocortisone and Insulin-Like hormone.And contain sterols materials such as 24-methylene cholesterol, stigmasterol, cupreol, avenasterol and cholesterol.When water is carried except the active ingredient in the medical material is extracted, compositions such as amounts of protein, tannin, starch, phlegmatic temperament have also been extracted, these compositions are not if remove, to influence mouthfeel, put for a long time also and can produce precipitation, product quality is exerted an influence, so we do not handle Lac regis apis in former invention.Then we through further technical study discovery, adopt the alcohol deposition method remove impurity to Lac regis apis on former basis, invalid element fully can be removed; Not only quality is guaranteed, and curative effect is significantly improved.
Below set forth clinical efficacy by the clinical trial example by the oral liquid of preparation method gained of the present invention.
Test the clinical observation of routine preparation method oral liquid of the present invention
The oral liquid that gets by preparation method of the present invention is Chinese medicine preparation sheerly, be a kind of novel strengthening by means of tonics health care medicine, in order to confirm its clinical efficacy, the inventor now is summarized as follows the result the clinical contrast observation that No. 1 Hospital Affiliated to Hunan Traditional Chinese Medical College has carried out the auxiliary treatment of relevant disease:
One, physical data
Case is selected and grouping: the object of observation is the outpatient service and the inpatient in February, 2000~May, is divided into two groups by the order of going to a doctor and be in hospital, and gives oral liquid of the present invention and LIUWEI DIHUANG WAN, ginseng royal jelly's treatment respectively.Two groups of primary conditions see Table one:
Table one or two group primary condition
Rank |
Sex |
Age |
The man |
The woman |
18-39 |
40-80 |
Oral liquid group of the present invention |
12 |
18 |
14 |
16 |
Matched group |
13 |
7 |
7 |
11 |
The sick kind: neurasthenia, insomnia, anemia, early coronary disease, arteriosclerosis etc.
Two, Therapeutic Method
Oral liquid group of the present invention a: 10ml, every day twice, sub-service sooner or later.
Matched group: LIUWEI DIHUANG WAN, ginseng royal jelly, choose any one kind of them conventional the use.
More than two groups be a course of treatment around all.
Three, therapeutic outcome
Criterion of therapeutical effect: 1, produce effects: A, clinical symptom disappearance, B, lab index inspection transfer to more than 2 normally; 2, take a turn for the better: A, clinical symptoms by +++or ++ transfer to+, B, improvement of lab index; 3, invalid: A, cardinal symptom do not have improvement, and B, lab testing do not have change.
Result and analysis:
1, two groups of curative effects relatively: see Table 2, oral liquid group of the present invention as can be seen from Table 2 and matched group curative effect be different significance.
Table 2 liang group curative effect relatively
Group |
Produce effects |
Take a turn for the better |
Invalid |
Add up to |
Oral liquid group of the present invention |
22 |
5 |
3 |
30 |
Matched group |
4 |
11 |
5 |
20 |
Add up to |
26 |
16 |
8 |
50 |
X
2=13.76,P<0.005
2, two groups of comparisons that insomnia, Hb, WBC improved situation: see Table 3, table 4, table 5.Can find out that from table 2 oral liquid of the present invention has good therapeutical effect to insomnia, and two groups of differences there is significance.P<0.005
Table 3 liang group is to the comparison of insomnia curative effect
Group |
Produce effects |
Take a turn for the better |
Invalid |
Add up to |
Oral liquid group of the present invention |
21 |
4 |
2 |
27 |
Matched group |
3 |
6 |
4 |
13 |
Add up to |
24 |
10 |
6 |
40 |
X
2=11.07,P<0.005
Table 4 liang group is to the comparison of Hb curative effect
Group |
Raise |
Reduce |
Add up to |
Oral liquid group of the present invention |
20 |
4 |
22 |
Matched group |
2 |
4 |
6 |
Add up to |
22 |
6 |
23 |
Table 5 liang group is to the comparison of WBC curative effect
Group |
Raise |
Reduce |
Add up to |
Oral liquid group of the present invention |
15 |
7 |
22 |
Matched group |
7 |
5 |
12 |
Add up to |
22 |
12 |
34 |
P=0.25
3, oral liquid of the present invention is to the comparison of three kinds of different pattern of syndrome curative effects: the curative effect difference that sees Table 6, three groups of different pattern of syndrome does not have significance.
Table 6 oral liquid of the present invention compares the curative effect of deficiency of qi and blood, deficiency of the liver and kindey and three kinds of pattern of syndrome of hyperactivity of YANG due to deficiency of YIN
Group |
Produce effects |
Take a turn for the better |
Invalid |
Add up to |
Deficiency of qi and blood |
11 |
1 |
1 |
13 |
Deficiency of the liver and kindey |
7 |
3 |
1 |
11 |
Hyperactivity of YANG due to deficiency of YIN |
4 |
1 |
1 |
6 |
Add up to |
22 |
5 |
3 |
30 |
Four, conclusion
All do liver, kidney function test before and after two groups of cases are taken medicine and all do not have influence, also do not have the 1 routine state of an illness to increase the weight of, two groups of equal non-evident effects of medicine are described.By above clinical trial as seen, the oral liquid of the present invention that gets by prepared after improving all has the effect of auxiliary treatment to diseases such as neurasthenia, insomnia, anemia, early coronary disease, arteriosclerosis, and acts on obvious more eager to excel in whatever one does than matched group.Especially quite remarkable to the deficiency of qi and blood type effect, can significantly improve insomniac's sleep quality.Therefore, for the patient who suffers from above-mentioned disease, the selection of a kind of best adjuvant drug of can yet be regarded as.
Below further set forth preparation method of the present invention by specific embodiment.
The preparation of embodiment 1 present composition oral liquid
Take by weighing Cortex Acanthopancis 100g, Herba Epimedii 200g, bee pollen 50g, Lac regis apis 40g, Mel 720g; Cortex Acanthopancis, Herba Epimedii are added 5 times of amounts of water decocted 1 hour, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected; Medicinal residues add 3 times in water amount and decocted 1 hour, and collecting decoction filters, and filtrate decompression is condensed into clear paste, add ethanol and reach 55% to containing the alcohol amount, stir, and leave standstill, and filter, and filtrate recycling ethanol is evaporated to relative density and is about ± 1.10 clear paste, and is standby; Other gets bee pollen 50g and adds the saccharifying enzyme processing, grinds, and filters filtrate for later use.Lac regis apis is added ethanol grind, filter, the filtrate after filtrate and bee pollen are handled merges, and reclaims ethanol to there not being the alcohol flavor, and is standby; Get Mel and be heated to 85-90 ℃, be incubated 30 minutes, defoam, impurity filters, filtrate is cooled to 35-38 ℃, add above-mentioned volatile oil, clear paste, bee pollen liquid and Lac regis apis concentrated solution, stir evenly, add the potassium sorbate of medicine liquid volume 0.05% again, use the Fructus Citri Limoniae acid for adjusting pH, keep within bounds into oral liquid 1000ml of the present invention.
Embodiment 2 present composition preparation of soft capsule
Take by weighing Cortex Acanthopancis 100g, Herba Epimedii 250g, bee pollen 70g, Lac regis apis 30g, Mel 500g; Cortex Acanthopancis, Herba Epimedii are added 7 times of amounts of water decocted 2 hours, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected; Medicinal residues add 2 times of amounts of water, decoct 0.6 hour, and collecting decoction filters, filtrate decompression is concentrated into relative density and is about ± 1.10 clear paste, and add ethanol and reach 50% to containing the alcohol amount, stir, leave standstill, filter, filtrate recycling ethanol is evaporated to relative density and is about ± 1.10 clear paste, and is standby; Other gets bee pollen and adds the saccharifying enzyme processing, grinds, and filters filtrate for later use.Lac regis apis is added ethanol grind, filter, the filtrate after filtrate and bee pollen are handled merges, and reclaims ethanol to there not being the alcohol flavor, and is standby; Get Mel and be heated to 85-90 ℃, be incubated 30 minutes, defoam, impurity filters, and filtrate is cooled to 35-38 ℃, with above-mentioned volatile oil and medicinal liquid, clear paste, bee pollen liquid and Lac regis apis concentrated solution, adopts dropping preparation method to make 1000 of present composition soft capsules.
The preparation of embodiment 3 present composition drop pills
Cortex Acanthopancis 120g, Herba Epimedii 140g are added 4 times of amounts of water decocted 1.5 hours, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected; Medicinal residues add 2 times of amounts of water, decoct 1 hour, and collecting decoction filters, filtrate decompression is concentrated into relative density and is about ± 1.10 clear paste, and add ethanol and reach 55% to containing the alcohol amount, stir, leave standstill, filter, filtrate recycling ethanol is evaporated to relative density and is about ± 1.10 clear paste, and is standby; Other gets bee pollen 70g and adds the saccharifying enzyme processing, grinds, and filters filtrate for later use.Lac regis apis 25g is added ethanol grind, filter, the filtrate after filtrate and bee pollen are handled merges, and reclaims ethanol to there not being the alcohol flavor, and is standby; Get Mel 450g and be heated to 85-90 ℃, be incubated 30 minutes, defoam impurity, filter, filtrate is cooled to 35-38 ℃, adds above-mentioned volatile oil, clear paste, bee pollen liquid and Lac regis apis concentrated solution, stir evenly, add an amount of PEG6000, adopt dropping preparation method to make 1000 of present composition drop pills.
The preparation of embodiment 5 present composition granules
Cortex Acanthopancis 100g, Herba Epimedii 200g are added 3 times of amounts of water decocted 1.5 hours, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected; Medicinal residues add 4 times of amounts of water, decoct 1.5 hours, and collecting decoction filters, filtrate decompression is concentrated into relative density and is about 1.15 clear paste, adds ethanol and reaches 50% to containing the alcohol amount, stirs, and leaves standstill, filter, filtrate recycling ethanol is evaporated to relative density and is about 1.15 clear paste, and is standby; Lac regis apis 30g is added ethanol grind, filter, the filtrate after filtrate and bee pollen are handled merges, and reclaims ethanol to there not being the alcohol flavor, and is standby; Other gets bee pollen 70g and adds the saccharifying enzyme processing, grinds, and filters filtrate for later use.Get Mel 750g and be heated to 80-85 ℃, be incubated 45 minutes, defoam, impurity filters, and filtrate is cooled to 30-35 ℃, stir evenly, add above-mentioned volatile oil, clear paste, bee pollen liquid and Lac regis apis concentrated solution, stir evenly, concentrating under reduced pressure becomes extractum, dry, be ground into fine powder, add corresponding adjuvant, drying and granulating is made present composition granule 1000 bags.
The preparation of embodiment 6 present composition oral liquids
Cortex Acanthopancis 150g, Herba Epimedii 100g are added 7 times of amounts of water decocted 2 hours, collect volatile oil simultaneously, standby, medicinal liquid device is in addition collected; Medicinal residues add 3 times of amounts of water, decoct 0.6 hour, and collecting decoction filters, and filtrate decompression concentrates clear paste, add ethanol and stir, and leave standstill, filter, and filtrate recycling ethanol, concentrating under reduced pressure becomes clear paste, and is standby; Other gets bee pollen 80g and adds the saccharifying enzyme processing, grinds, and filters filtrate for later use.Lac regis apis 50g is added ethanol grind, filter, the filtrate after filtrate and bee pollen are handled merges, and reclaims ethanol to there not being the alcohol flavor, and is standby; Add above-mentioned volatile oil, clear paste, bee pollen liquid and Lac regis apis concentrated solution, stir evenly; Keep within bounds into oral liquid 1000ml of the present invention.